Natural Alternatives International v. Creative Compounds (BIO Brief as Amicus Curiae)

The Biotechnology Innovation Organization (“BIO”) (formerly: Biotechnology Industry Organization) is the principal trade association representing the biotechnology industry domestically and abroad. BIO has more than 1,000 members, which span the for-profit and non-profit sectors and range from small start-up companies and biotechnology centers to research universities and Fortune 500 companies. Approximately 90% of BIO’s corporate members are small or midsize businesses that have annual revenues of under $25 million. 

BIO’s members are concerned that, six years after the Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), increasing uncertainty exists about the patent-eligibility of biotechnological products that incorporate naturally-occurring substances, and of methods of using such products in therapeutic, diagnostic, or industrial processes. The unstable state of patent-eligibility jurisprudence affects modern biotechnologies ranging from biomarker-assisted methods of drug treatment to companion diagnostic tests, fermentation products, industrial enzyme technology, and marker-assisted methods of plant breeding. As developers of, and investors in, such advanced technologies, BIO members have a strong interest in clear and predictable rules of patent-eligibility. Amicus BIO submits this brief in the hope that it will assist the Court in the orderly development of the law in this important area.